Islet Transplantation for Patients With Type 1 Diabetes

Status Completed

Clinical Trial Summary

This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with stable renal allografts by islet transplantation.

Clinical Trial Description

We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be transplanted into the portal vein of patients with T1DM who have stable renal allografts to achieve insulin independence for the recipient. The protocol will employ a defined islet isolation procedure, percutaneous islet infusion into the recipient's portal vein via an intra-portal catheter, tight glycemic control during the peri-transplant period, and an immunosuppressive protocol that avoids glucocorticoids. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Diabetes Mellitus, Type 1

Clinical Trial Details

NCT number	NCT00073281
Study type	Interventional
Source	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact
Status	Completed
Phase	Phase 1
Start date	August 2003
Completion date	December 2004

View Details

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